背景:非喷发性钙结节(CNs)常见于严重钙化的冠状动脉疾病。它们是最难修改的子集,并可能导致支架损坏,贴壁不良和膨胀不足。只有有限的选项可用于非爆发性CN修改。正在探索血管内碎石术(IVL)作为这些病变的潜在安全有效方式。
目的:本研究旨在研究使用IVL修饰非爆发性CNs的安全性和有效性。该研究还探讨了IVL修饰钙结节的OCT特征。
方法:这是一个单中心,prospective,纳入血管造影重度钙化和OCT显示非爆发性CN并接受PCI的患者的观察性研究。主要安全终点是无穿孔,无回流/慢流动,IVL治疗后的流量限制夹层,住院期间和30天的主要不良心脏事件(MACE)。MACE被定义为心脏死亡的复合物,心肌梗死(MI),和缺血驱动的靶病变血运重建(TLR)。主要疗效终点是手术成功,定义为血管造影术中残余直径狭窄<30%,OCT评估支架扩张超过80%。
结果:共有21例54例非发疹性CNs接受PCI的患者被前瞻性纳入研究。在IVL之前,OCT显示平均钙评分为3.7±0.5,CN处平均MLA为3.9±2.1mm2。IVL之后,OCT显示,54个CN中有40个(74.1%)有钙骨折,每个CN平均有1.05±0.72个骨折。主要在CN的基部观察到骨折(80%)。IVL后,CN处的平均MLA增加到4.9±2.3mm2。PCI后,CN处的平均MSA为7.9±2.5mm2。在85.71%的患者中,在CN处实现了最佳支架扩张(支架扩张>80%)。所有患者在住院期间和30天随访时都没有MACE。在1年的随访中,3例(14.3%)患者发生了全因死亡.
结论:这项单臂研究证明了安全性,功效,以及IVL在非喷发性钙化结节患者中的应用。在这项研究中,手术并发症最少,出色的病变修饰,观察到有利的30天和1年结局.
BACKGROUND: Non-eruptive calcium nodules (CNs) are commonly seen in heavily calcified coronary artery disease. They are the most difficult subset for modification, and may result in stent damage, malapposition and under-expansion. There are only limited options available for non-eruptive CN modification. Intravascular lithotripsy (IVL) is being explored as a potentially safe and effective modality in these lesions.
OBJECTIVE: This
study aimed to investigate the safety and efficacy of the use of IVL for the modification of non-eruptive CNs. The
study also explored the OCT features of calcium nodule modification by IVL.
METHODS: This is a single-center, prospective, observational
study in which patients with angiographic heavy calcification and non-eruptive CN on OCT and undergoing PCI were enrolled. The primary safety endpoint was freedom from perforation, no-reflow/slow flow, flow-limiting dissection after IVL therapy, and major adverse cardiac events (MACE) during hospitalization and at 30 days. MACE was defined as a composite of cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR). The primary efficacy endpoint was procedural success, defined as residual diameter stenosis of <30% on angiography and stent expansion of more than 80% as assessed by OCT.
RESULTS: A total of 21 patients with 54 non-eruptive CNs undergoing PCI were prospectively enrolled in the study. Before IVL, OCT revealed a mean calcium score of 3.7 ± 0.5 and a mean MLA at CN of 3.9 ± 2.1 mm2. Following IVL, OCT revealed calcium fractures in 40 out of 54 (74.1%) CNs with an average of 1.05 ± 0.72 fractures per CN. Fractures were predominantly observed at the base of the CN (80%). Post IVL, the mean MLA at CN increased to 4.9 ± 2.3 mm2. After PCI, the mean MSA at the CN was 7.9 ± 2.5 mm2. Optimal stent expansion (stent expansion >80%) at the CN was achieved in 85.71% of patients. All patients remained free from MACE during hospitalization and at the 30-day follow-up. At 1-year follow-up, all-cause death had occurred in 3 (14.3%) patients.
CONCLUSIONS: This single-arm
study demonstrated the safety, efficacy, and utility of the IVL in a subset of patients with non-eruptive calcified nodules. In this
study, minimal procedural complications, excellent lesion modifications, and favorable 30-day and 1-year outcomes were observed.